36 results · 27ms · Sources: EU EUDAMED, US FDA

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Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS

FDA 510(k)
FDA Class 2 ·Immunology

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100240·SILICONE TUBING FOR ASPIRATING SPECULUM

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE

MaxFuse,VBR, 12 (D) x 14 (W) x 35 (H)

FDA UDI
Pioneer Surgical Technology, Inc.·00846468056339·12 (D) x 14 (W) x 35 (H)

QUANTUM RING FIXATION SYSTEM MODEL ISF

FDA 510(k)
FDA Class 2 ·Orthopedic

FLEXI-LITE, MODEL FL-V1.2

FDA 510(k)
FDA Class 2 ·Anesthesiology

ROSA ONE

FDA Adverse Event
Injury ·MEDTECH SA·Product code HAW·November 10, 2017

ROSA ONE

FDA Adverse Event
Malfunction ·MEDTECH SA·Product code HAW·April 11, 2018

ROSA ONE

FDA Adverse Event
Malfunction ·MEDTECH SA·Product code HAW·March 15, 2018

ROSA ONE

FDA Adverse Event
Injury ·MEDTECH SA·Product code HAW·June 15, 2018

ROSA ONE

FDA Adverse Event
Malfunction ·MEDTECH SA·Product code HAW·November 10, 2017

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

ROSA ONE

FDA Adverse Event
Malfunction ·MEDTECH SA·Product code HAW·March 21, 2018

ROSA ONE

FDA Adverse Event
Malfunction ·MEDTECH SA·Product code HAW·November 16, 2017

ROSA ONE

FDA Adverse Event
Malfunction ·MEDTECH SA·Product code HAW·November 9, 2017

ROSA ONE

FDA Adverse Event
Malfunction ·MEDTECH SA·Product code HAW·January 26, 2018

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 6, 2011

INTRALASE LASER

FDA Adverse Event
Injury ·INTRALASE CORP·Product code GEX·June 3, 2013

STERLING?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·October 8, 2014

ROSA ONE

FDA Adverse Event
Malfunction ·MEDTECH SA·Product code HAW·November 6, 2017